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Clinical Trials List

Protocol Number42756493BLC2001
NCT Number(ClinicalTrials.gov Identfier)NCT02365597
Completed

2015-04-20 - 2019-12-31

Phase II

Terminated4

ICD-10C67

Malignant neoplasm of bladder

A Phase 2, Two-arm Multicenter, Open-Label Study to Determine the Efficacy and the Safety of Two Different Dose Regimens of a pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Subjects with Metastatic or Surgically Unresectable Urothelial Cancer with FGFR Genomic Alterations

  • Trial Applicant

    Johnson & Johnson

  • Sponsor

    Janssen Research & Development, LLC

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Wen-Pin Su Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Audit

None

Principal Investigator Shian-Shiang Wang Division of Urology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator See-Tong Pang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Audit

None

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Audit

None

Condition/Disease

Urothelial Cancer

Objectives

To evaluate the objective response rate (complete response [CR]+ partial response [PR]) of the selected dose regimen out of 2 possible regimens (Regimen 1: 10 mg dose, 7 days on/7 days off; and Regimen 2: 6 mg dose, 21 days on/7 days off) in subjects with metastatic or surgically unresectable urothelial cancers that harbor specific FGFR genomic alterations.

Test Drug

JNJ-42756493(Erdafitinib)

Active Ingredient

JNJ-42756493

Dosage Form

tablet

Dosage

3
4
5

Endpoints

Primary Outcome Measures :
1. Percentage of Participants with Best Overall Response [ Time Frame: From the start of the study treatment until the end of treatment (1 year) ]
The objective response rate is defined as the percentage of participants with measurable lesions achieving a Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria In Solid Tumors Version 1.1(RECIST v1.1) criteria. Per RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to (>=) 30 percent (%) decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Inclution Criteria

Inclusion Criteria:
• Must have histologic demonstration of metastatic or surgically unresectable urothelial cancer. Minor components of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable
• Must have measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at baseline
• Must have an Eastern Cooperative Oncology Group (ECOG) performance status score 0, 1, or 2
• Must have adequate bone marrow, liver, and renal function as described in protocol
• Negative pregnancy test (urine or serum beta human chorionic gonadotropin [b-hCG]) at Screening for women of child bearing potential who are sexually active
• Must have shown disease progression according to RECIST, version 1.1, following prior chemotherapy for metastatic or surgically unresectable urothelial cancer. Participants who received neoadjuvant or adjuvant chemotherapy and showed disease recurrence or progression according to RECIST, version 1.1, within 12 months of the last dose are considered to have received chemotherapy in the metastatic setting. These participants will be referred to as chemo-refractory participants. (Participants who have shown disease progression according to RECIST, version 1.1 following prior treatment with anti-Programmed death-ligand 1 (anti PDL1/PD1) antibodies are also eligible) For DDI substudy
• Disease progression following prior chemotherapy for metastatic or surgically unresectable urothelial cancer. Participants who received neoadjuvant or adjuvant chemotherapy and showed disease recurrence or progression within 12 months of the last dose are considered to have received chemotherapy in the metastatic setting.

Exclusion Criteria

Exclusion Criteria:
• Received chemotherapy, targeted therapies, definitive radiotherapy, or treatment with an investigational anticancer agent within 2 weeks (in the case of nitrosoureas and mitomycin C, within 6 weeks; in the case of immunotherapy, within 4 weeks) before the first administration of study drug. Localized palliative radiation therapy (but should not include radiation to target lesions) and ongoing bisphosphonates and denosumab, are permitted
• Has persistent phosphate level greater than upper limit of normal (ULN) during screening (within 14 days of treatment and prior to Cycle 1 Day 1) and despite medical management
• Has a history of or current uncontrolled cardiovascular disease
• Females who are pregnant, breast-feeding, or planning to become pregnant within 3 months after the last dose of study drug and males who plan to father a child while enrolled in this study or within 5 months after the last dose of study drug
• Has not recovered from reversible toxicity of prior anticancer therapy (except toxicities which are not clinically significant such as alopecia, skin discoloration, or Grade 1 neuropathy)

The Estimated Number of Participants

  • Taiwan

    8 participants

  • Global

    165 participants

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